EndoNaut
Therenva SASEndoNaut is a software system designed to aid physicians during fluoroscopy X-ray guided procedures by overlaying preoperative 3D vascular anatomy onto live fluoroscopy images. It assists in accurately positioning surgical tools and endovascular devices in the chest, abdomen, pelvis, neck, and lower limbs for treatments like aneurysm repair and arterial embolization. This image fusion and navigation tool enhances procedural accuracy, although it does not replace the surgeon's judgment and requires real-time imaging confirmation before device deployment.
Intended Use
EndoNaut is an image fusion software solution and computerized navigational system intended to assist X-ray fluoroscopy-guided procedures in the positioning of surgical instruments and endovascular devices in the chest, abdomen, pelvis, neck and lower limbs, such as aneurysm repair, artery/vein embolization, or peripheral artery disease treatment.
Technology
EndoNaut consists of software installed on a hardware workstation enabling image display and user interaction. It interoperates with EndoSize planning software for preoperative strategy and device selection. The system overlays 3D vessel anatomy images onto live 2D fluoroscopic images, with features including 3D/2D registration, motion detection, and contrast injection detection powered by machine-learning algorithms. The software architecture has been updated to a client-server model but retains the same functionality. Hardware requirements and interoperability details are provided, including compatibility with Windows 10 and specific monitors.
Performance
The device was validated via design verification, unit and integration testing, clinical evaluation reports, usability tests, and electromagnetic and electrical safety testing. Verification and validation demonstrated performance equivalence of new software architecture variant compared to predicate standalone software. The system complies with relevant standards including IEC 62304, ISO 14971, IEC 60601 series, and other applicable safety and usability standards. Clinical studies were not required to support equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/14/2022
3 months - 2
FDA Approval
10/25/2022
Other devices from Therenva SAS
- EndoNaut2021 • 510K
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